Kornimate/medical-research-clean huggingface dataset:
role of vitamin d in secondary prevention of cardiovascular events

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to determine if vitamin d supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. this study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin d3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.

the purpose of this study is to determine if vitamin d supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. this study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin d3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.

Eligibility criteria:
inclusion criteria: * male or female of age \> 19 years at the time informed consent is signed. * subject with a diagnosis of unstable angina (with thrombolysis in myocardial infarction (timi) score of greater than or equal to 3) / nstemi or stemi,or documented coronary artery disease defined as at least one coronary artery with \> 50% occlusion * subject who is able to come back to our clinic for follow up visits for at least 1 year after enrollment. exclusion criteria: * subject is on treatment with either phenytoin or phenobarbitol or orlistat (since these medications may cause vitamin d deficiency). * subject who needs two or more steroid bursts per year for other co-morbid conditions (since steroids may impair vitamin d metabolism). * subject is on an investigational drug, which is a new drug class and not part of standard acs protocol. * subject is taking supplements of vitamin d with doses \>400 iu/day. * subject has hypersensitivity to vitamin d products. * subject has history of systemic lupus erythematosus (since vitamin d deficiency is common in this group27). * subject has history of sarcoidosis (since they have hypercalcemia and high levels of vitamin d28) * subject has history of renal stones. * subject has hypercalcemia, which is defined as serum calcium levels \>10.6 mg/dl, at the time of screening. * subject has end stage renal disease, defined as either chronic kidney disease stage v or requiring dialysis (since these patients have altered vitamin d and calcium metabolism). * subject has systemic disease (including terminal cancer, cirrhosis, end stage copd etc.,) with reduced (\<12 months) life expectancy. * subject has a history of psychiatric illness/condition that would interfere with his/her ability to understand or complete the requirements of the study. * subject has any condition that in the opinion of the investigator places the subject at an unacceptable risk as a participant in this study. * subject is pregnant.

Keywords: vitamin d cardiac catheterization cardiovascular event cardiovascular disease
navigation on head and neck radiotherapy

Conditions: Head and Neck Cancer

Summary: the aim of this experimental study is to evaluate the effect of nurse navigation in the management of symptoms associated with head and neck radiotherapy. all head and neck cancer patients who meet the study criteria of the radiation oncology clinic of selçuk university medical faculty hospital will be included in the study. according to the previously prepared randomization list, the study group consisted of a total of 88 people, 41 in the experimental group and 47 in the control group. while the standard treatment approaches of the hospital are applied to all patients, a nursing navigation program will be applied in addition to the patients in the experimental group.quality of life and toxicity criteria will be applied to all patients as measurement tools.

the navigation program will be started on the day patients start their treatment. before starting radiotherapy on the first day of radiotherapy, patients will be given a visual education guide about the radiotherapy treatment and the expected side effects. afterwards, there will be a weekly follow-up with phone reminders. inclusion criteria in the study; being over the age of 18, the patient whose treatment and follow-up will continue for 7 weeks, patient diagnosed with head and neck cancer, scheduled to receive radiotherapy, patients who verbally and in writing approved to participate in the study after the explanation about the research. exclusion criteria from the study; metastasis development in the patient, refusing to participate in the research after the explanation about the research, the patient himself / herself wants to leave the study.for all patients included in the study, informed consent forms will be obtained just before starting treatment, and the patient identification form, ctcae v5.0 toxicity criteria and eortc qlq-h \& n35 scales will be applied. quality of life measurements will be repeated at the end and middle of the treatment. in addition, weight measurements and laboratory follow-up of the patients will be done at the beginning and at the end of the study. ncss (number cruncher statistical system) 2007 program will be used for statistical analysis. descriptive statistics, parametric and non-parametric tests will be used to evaluate data.

Eligibility criteria:
inclusion criteria: * being literate * being over the age of 18 * the patient whose treatment and follow-up will continue for 7 weeks * patient diagnosed with head and neck cancer, scheduled to receive radiotherapy * patients who verbally and in writing approved to participate in the study after the explanation about the research exclusion criteria: * metastasis development in the patient * refusing to participate in the research after the explanation about the research. * the patient himself / herself wants to leave the study. * treatment interruption for more than 2 days due to deterioration of the general condition of the patient * taking the patient into intensive care

Keywords: radiotherapy navigation nursing symptom management quality of life toxicity
evaluation of imsi to treat male infertility

Conditions: Infertility

Summary: intracytoplasmic morphologically selected sperm (imsi) is a modification of intracytoplasmic sperm injection (icsi) with a choice of the spermatozoon to be injected done at a 6000x magnification instead of 400x commonly used in icsi. the purpose of this study is to evaluate the efficiency and the indications of imsi through a multicentric randomised trial.

intracytoplasmic sperm injection (icsi) is largely used to treat male infertility. usually, choice of the spermatozoon to be injected is done at a 400x magnification. recently, a new microscopic technic (intracytoplasmic morphologically selected sperm injection-imsi) allows to make this choice at a 6000x magnification, which permits to identify sperm abnormalities such as nuclear vacuoles not seen in conventional icsi. this selection may improve icsi outcome. however only few data from randomised trials, have been published and the indications of imsi remain to be identified. the present study aims to evaluate the efficiency and the indications of imsi through a multicentric randomised trial. the patients enrolled in the study must present a male infertility and will have complete sperm examination, including morphology, dna fragmentation and nuclear immaturity. the main endpoint will be the percentage of delivery.

Eligibility criteria:
inclusion criteria: * male infertility with less than 1 million of motile spermatozoa recovered after gradient preparation and at least 3 millions of sperm cells in the ejaculate * first assisted reproductive technology (art) attempt exclusion criteria: * female age \> 38 * female follicle stimulating hormone (fsh) level \> 9

Keywords: imsi icsi art assisted reproductive technology spermatozoa male infertility vacuoles
reward-based recovery outcomes management for opioid use disorder

Conditions: Opioid Use Disorder

Summary: a randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (procare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * access to internet-enabled smartphone device * primary dsm-5 opioid use disorder diagnosis * receiving medication treatment for opioid use disorder with buprenorphine * english language proficient exclusion criteria: * active suicidal ideation or psychotic symptoms
11c-methionine pet/ct imaging in patients affected by malignant pleural mesothelioma (mpm)

Conditions: Mesothelioma, Malignant

Summary: prospective exploratory study specifically investigating the role of 11c-methionine pet/ct imaging in patients affected by malignant pleural mesothelioma (mpm) and candidate to pleurodesis.

this is a single-center, open-label study, lasting 36 months including an estimated period of 24 months for the enrollment and max 12 months of follow-up. all patients affected by mpm and referred to our institution eligible for therapeutic pleurodesis and subsequent platinum- and pemetrexed-based chemotherapy will be enrolled. in all cases patients will be investigated with 11c-methionine pet/ct and 18f-fdg pet/ct before talc pleurodesis, one week after and at the end of three cycles of chemotherapy. a minimum number of 20 patients will be considered for the analysis.

Eligibility criteria:
inclusion criteria: * patients with an histological diagnosis of mpm eligible for pleurodesis and scheduled to undergo platinum- and pemetrexed-based chemotherapy. * obtained informed consent exclusion criteria: * patients age \<18 years * pregnancy or breast-feeding; * patients affected by other malignancies within the last 3 years;

Keywords: mesothelioma 11c-methionine pet talc pleurodesis
carbohydrate rinsing and caffeine gum on performance of romanian deadlifts performance

Conditions: Carbohydrate; Caffeine

Summary: two experiments were completed to investigate the effects of carbohydrate mouth rinsing and caffeine gum chewing on inertial resistance exercise performance. it was found that both carbohydrate gargling and caffeine gum chewing could improve inertial resistance exercise performance.

this study compared the effects of mouth rinsing with carbohydrates trial (cmr) or a placebo trial (pl) on inertial weight training performance with an inertial weight resistance device. the participants were recruited in this study. participants were randomly allocated to the cmr and pl groups and subjected to a crossover experiment in which they performed maximum inertial resistance training comprising five sets of six reps, with 3-min rests between sets. after deducting the first repetition of each sets, the mean values from the five sets were analyzed.

Eligibility criteria:
inclusion criteria: 1. regular weight training habits, 2. familiarity with romanian deadlift movements 3. no chronic diseases such as hypertension, diabetes, and kidney disease or sports injuries such as lacerated knee ligaments, inflammation and rupture of tendons, strained biceps femoris or quadriceps, and strained biceps within the 6 months prior. exclusion criteria: 1. did not have regular exercise habits, 2. were unfamiliar with romanian deadlift movements 3. had certain health problems that prevented them from performing exercise or injury from which they had not recovered for more than 6 months were excluded.

Keywords: eccentric exercise
a study to evaluate the safety of ozanimod exposure during pregnancy in women with multiple sclerosis and their infants

Conditions: Multiple Sclerosis

Summary: the purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with multiple sclerosis (ms) who were exposed to ozanimod during pregnancy; the second is women with ms exposed to select other disease-modifying therapies (dmts) during pregnancy; the third is women with ms not exposed to any dmts during pregnancy. this study will use data from a large us healthcare claims database.


Eligibility criteria:
inclusion criteria: * women aged 18 to 49 years at date of conception * date of conception between april 1, 2020 and july 31, 2030 exclusion criteria: * pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes) * exposure to the dmts fingolimod, siponimod, mitoxantrone, and teriflunomide within a period of 5 half-lives prior to the estimated date of conception through the end of the first trimester
the role of reactive thrombocytosis in children with pneumococcal infection

Conditions: Thrombocytosis; S. Pneumoniae Infection

Summary: thrombocytosis, mostly reactive in nature, is common in pediatric hospitalized patients with infections. streptococcus pneumoniae (s. pneumoniae) is the most common pathogen. in this study, the investigators investigated the associations of clinical profiles and thrombocytosis and evaluated platelet counts, leukocyte counts and crp levels as predictors of hospitalization days in patients with s. pneumoniae infection.


Eligibility criteria:
inclusion criteria: * pediatric patients diagnosed with pneumococcal infection. exclusion criteria: * patients with automatic discharge.

Keywords: s. pneumoniae thrombocytosis pediatric patients the study aimed to understand the diagnostic value of thrombocytosis in children with s. pneumoniae infection
dexamethasone in the prevention of post-spinal paralytic ileus after cesarean section

Conditions: Postoperative Ileus

Summary: postoperative ileus is a perplexing problem for clinical surgeons. it occurs not only after abdominal surgery but also after any surgery that requires general anesthesia. postoperative ileus is defined as the dysfunction of gastrointestinal motility after surgery, characterized by a decrease in, or stagnation of, intestinal peristalsis.

common clinical manifestations include abdominal pain, abdominal distention, nausea, vomiting, delayed flatus, delayed defecation, and inability to consume orally. postoperative ileus is an uncomfortable experience, enhances the possibility of postoperative complications, prolongs hospital stay, and increases the economic burden. postoperative gastrointestinal function recovery is of great concern. there is currently an urgent need to improve postoperative recovery of gastrointestinal function. the mechanism of postoperative ileus varies, including autonomic regulation, inflammatory response, gastrointestinal hormones, and postoperative use of opioid drugs. surgical gut damage destroys the intestinal barrier, stimulates the sympathetic and parasympathetic nervous systems, and enhances the release of inflammatory factors. these factors precipitate the occurrence of postoperative ileus. the current use of laparoscopic techniques can reduce incision size and surgical trauma, enabling careful manipulation.

Eligibility criteria:
inclusion criteria: * •all participants will sign an informed consent prior to inclusion in the study. * all patients 18-40 years of full-term singleton pregnancy (37-41 weeks)., * american society of anaesthesiologists (asa) classification class i and ii scheduled. * for elective or semi-elective surgery (category 3 and 4 caesarean sections). * all patients under spinal anesthesia for a single baby pregnancy of more than 32 weeks will be included in this study. exclusion criteria: * will be patients' height \ 180 cm. * body mass index (bmi) \>35 kg m-2. * contraindication or refusal to undergo regional anesthesia. * any cardiovascular disease including arrhythmias and severe stenotic valvular heart disease.any renal or hepatic diseased patients.
lung volume reduction coils for emphysema in alpha-1 antitrypsin deficiency

Conditions: Alpha-1-Antitrypsin Deficiency; Chronic Obstructive Lung Disease; Emphysema

Summary: the objective of this study is to evaluate the safety and effectiveness of the repneu lung volume reduction coil (lvrc) in patients with alpha-1-antitrypsin deficiency (aatd) caused emphysema. the hypothesis is that emphysema in aatd patients shows similar tissue destruction profile was well as symptoms and thus will respond favorably to lvrc treatment, demonstrating improvement in lung function, exercise capacity, and quality of life relative to their baseline status.


Eligibility criteria:
inclusion criteria: 1. patient \> 18 years of age, diagnosed with aatd emphysema 2. ct scan indicates bilateral heterogeneous or non-severe homogeneous emphysema, with sufficient lung parenchyma for coil deployment, in accordance with manufacturer recommendations (see section 5.2.4.1). 3. patient has post- bronchodilator fev1 less than or equal to 45% predicted 4. total lung capacity \> 100% 5. residual volume (rv) \>175% predicted 6. patient has stopped smoking for a minimum of 8 weeks prior to entering the study 7. patient has read, understood and signed the informed consent form 8. patient is willing and able to attend all required follow-up visits 9. patient is willing and able to undergo bilateral lvrc treatment 10. patient has received pneumococcal and influenza vaccinations consistent with local recommendations and/or policy exclusion criteria: 1. patient has a change in fev1 \> 20% post-bronchodilator. 2. patients dlco \< 20% predicted 3. patient has a history of recurrent clinically significant respiratory infection 4. patient has uncontrolled pulmonary hypertension defined by right ventricular pressure \>50mmhg and or evidenced by echocardiogram 5. patient has an inability to walk \>140 meters (150 yards) in 6 minutes 6. patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc. 7. patient is pregnant or lactating 8. patient has an inability to tolerate bronchoscopy under moderate sedation or anesthesia 9. patient has clinically significant bronchiectasis 10. patient has giant bullae \> 1/3 lung volume 11. patient has had previous lvr surgery, lung transplant or lobectomy 12. patient has been involved in other pulmonary drug or device studies with 30 days prior to this study 13. patient is taking \> 20mg prednisone (or similar steroid) daily 14. patient is on an antiplatelet agent (such as plavix) or anticoagulant therapy (such as heparin or coumadin) or has not been weaned off prior to procedure 15. patient has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes 16. patient has severe homogeneous emphysema by ct scan.
drug-drug interaction study of kl1333 in healthy subjects

Conditions: Mitochondrial Disease

Summary: a phase i, open-label, fixed-sequence, crossover, drug-drug interaction study to investigate the inhibition potential of kl1333 on cyp1a2, cyp2b6, cyp2c8, cyp2c9, cyp2c19, cyp2d6, and cyp3a4 in healthy subjects

this will be a phase i, open-label, fixed-sequence, crossover study to investigate the effect of coadministration of kl1333 on the pk of repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy male and female subjects. potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. subjects will be admitted into the clinical research unit (cru) on day -1 and be confined to the cru until discharge on day 19. subjects will return to the cru for a follow-up visit 5 to 7 days after the last dose.

Eligibility criteria:
inclusion criteria: 1. males or females, of any race, between 18 and 65 years of age, inclusive. 2. weight ≥50 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive. 3. in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ecg, vital signs measurements, and clinical laboratory evaluations (congenital nonhaemolytic hyperbilirubinaemia \[eg, suspicion of gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in as assessed by the investigator. 4. females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in appendix 4. 5. able to comprehend and willing to sign an icf and to abide by the study restrictions. 6. able to perform all protocol-specified assessments and comply with the study visit schedule. exclusion criteria: 1. significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator. 2. history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including kl1333 or its excipients, unless approved by the investigator. 3. history of gastroesophageal reflux disease, gastric erosions, peptic ulcer disease, or gastrointestinal bleeding episodes. 4. history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs including cholecystectomy (uncomplicated appendectomy and hernia repair will be allowed). 5. history of malignancy of any organ system other than localised basal cell carcinoma of the skin, treated or untreated, within 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases. 6. history of clinically significant illness or surgery within 4 weeks prior to screening, as determined by the investigator.
role of prophylactic tranexamic acid in prevention of post-partum hemorrhage in ellscs

Conditions: Post Partum Hemorrhage

Summary: in this study women under going ellscs would be divided into two groups , one group would be given tranexamic acid while the other would be getting placebo prophylactically to see the effect of tranexamic acid in preventing pph. this is a randomized controlled trial. the sampling technique would be non-probability technique randomization would be done via balloting method.


Eligibility criteria:
inclusion criteria: * pregnant women with singleton pregnancy and low risk for pph admitted for ellscs exclusion criteria: women with medical disorder or complex pregnancy. * women with history of pph. * women with bleeding disorder. * abnormal placentation (map, placenta previa) * multiple pregnancy.